Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial
In: European Journal of Cancer European Journal of Cancer, 2020, 124, pp.91-101. ⟨10.1016/j.ejca.2019.10.020⟩ European Journal of Cancer, Elsevier, 2020, 124, pp.91-101. ⟨10.1016/j.ejca.2019.10.020⟩; (2020)
Online
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Zugriff:
International audience; PURPOSE: This Phase IIb (NCT02195180) open-label study evaluated erythrocyte-encapsulated asparaginase (eryaspase) in combination with chemotherapy in second-line advanced pancreatic adenocarcinoma.METHODS: Eligible patients were randomized 2:1 to either eryaspase in combination with gemcitabine or mFOLFOX6 (eryaspase arm), or to gemcitabine or mFOLFOX6 alone (control arm). Co-primary endpoints were overall survival (OS) and progression-free survival (PFS) in patients with low asparagine synthetase (ASNS) expression. Secondary endpoints included OS and PFS in the entire population.RESULTS: 141 patients were randomized (eryaspase arm, n = 95; control arm, n = 46). Median OS and PFS in patients with low ASNS expression were 6.2 months (95% CI, 5.1-8.8) in the eryaspase arm versus 4.9 months (3.1-7.1) in the control arm (HR, 0.63; 95% CI, 0.39-1.01; P = 0.056) and 2.0 months (95% CI, 1.8-3.4) in the eryaspase arm versus 1.8 months (1.4-3.8) in the control arm (HR, 0.67; 95% CI, 0.40-1.12; P = 0.127), respectively. In the entire population, median OS and PFS for the eryaspase arm versus control were 6.0 months versus 4.4 months (HR, 0.60; P = 0.008) and 2.0 months versus 1.6 months (HR, 0.56; 95% CI, 0.37-0.84; P = 0.005), respectively. The combination of eryaspase and chemotherapy was well tolerated. The most frequent Grade 3/4 adverse events in the eryaspase arm (n = 93) were gamma-glutamyltransferase increase (16 [17.2%]), neutropenia (12 [12.9%]), and physical health deterioration (12 [12.9%]).CONCLUSION: Eryaspase in combination with chemotherapy is associated with improvements in OS and PFS, irrespective of ASNS expression in second-line advanced pancreatic adenocarcinoma. A Phase III trial is underway.
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Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial
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| Autor/in / Beteiligte Person: | Bouché, Olivier ; Iman El Hariry ; Lecomte, Thierry ; André, Thierry ; Tougeron, David ; Cros, Jérôme ; Hamm, Adam ; Bachet, Jean-Baptiste ; Metges, Jean-Philippe ; Rebischung, Christine ; Hammel, Pascal ; Mineur, Laurent ; Tournigand, Christophe ; Louvet, Christophe ; Farid El Hajbi ; Fabienne, Portales ; Kay, Richard ; Guimbaud, Rosine ; Gupta, Anu ; Faroux, Roger ; Christelle De La Fouchardiere ; Beaujon, Hôpital ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) ; Institut Sainte Catherine [Avignon] ; Centre Hospitalier Régional Universitaire de Brest (CHRU Brest) ; CHU Saint-Antoine [AP-HP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU) ; Sorbonne Université (SU) ; Centre Léon Bérard [Lyon] ; Service d'Oncologie Médicale [Montsouris] ; Institut Mutualiste de Montsouris (IMM) ; Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille) ; Université de Lille-UNICANCER ; Service de chirurgie digestive (CH de La Roche-sur-Yon) ; Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée) ; Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037) ; Université Toulouse III - Paul Sabatier (UT3) ; Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM) ; Centre hospitalier universitaire de Poitiers (CHU Poitiers) ; Centre Hospitalier Universitaire de Reims (CHU Reims) ; CHU Trousseau [Tours] ; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours) ; Service d'Oncologie médicale [CHU Henri Mondor] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Henri Mondor [Créteil] ; Centre de recherche sur l'Inflammation (CRI (UMR_S_1149 / ERL_8252 / U1149)) ; Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS) ; CHU Pitié-Salpêtrière [AP-HP] ; Université Lille Nord de France (COMUE)-UNICANCER ; Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon ; Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM) ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Henri Mondor ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Diderot - Paris 7 (UPD7) ; Service de gastroentérologie et cancérologie digestive [CHU Pitié-Salpêtrière] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP] ; Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU) ; Hôpital Beaujon-Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP) ; CHU Saint-Antoine [APHP] ; CRLCC Oscar Lambret ; Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Henri Mondor ; Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP] ; Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière] ; Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) |
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| Quelle: | European Journal of Cancer European Journal of Cancer, 2020, 124, pp.91-101. ⟨10.1016/j.ejca.2019.10.020⟩ European Journal of Cancer, Elsevier, 2020, 124, pp.91-101. ⟨10.1016/j.ejca.2019.10.020⟩; (2020) |
| Veröffentlichung: | HAL CCSD, 2020 |
| Medientyp: | unknown |
| ISSN: | 0959-8049 (print) |
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